RecruitingNot ApplicableNCT07225205

Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy

Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy: A Randomized Controlled Trial

Sponsor

Johns Hopkins University

Enrollment

130 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer Muscle Invasive Bladder Cancer (MIBC)Muscle Invasive Bladder Cancer Urothelial Carcinoma Cystectomy

Summary

Radical cystectomy is the standard of care for muscle invasive bladder cancer, however despite advances, it is still associated with high morbidity. Many complications may be driven by dehydration and it is unclear if a home intravenous fluid (IVF) infusion program post-operatively, which is an accepted standard practice, is beneficial. This study is a single institution randomized controlled trial where patients who choose to undergo radical cystectomy for bladder cancer will be randomized to an Enhanced Recovery After Surgery (ERAS) protocol with a home IVF program, consisting of 1 liter (L) of crystalloid fluid three times per week for four weeks, or ERAS protocol alone. The primary outcome will be 90-day hospital re-admissions, with secondary outcomes including 30 and 90 day complications.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether patients who go home with intravenous (IV) fluids after bladder removal surgery (radical cystectomy) recover better than those who receive standard post-surgical care without home IV fluids. Dehydration after this surgery is a common reason patients return to the hospital, and researchers want to find out if IV fluids at home can reduce that risk. **You may be eligible if...** - You are 18 years or older - You have confirmed bladder cancer (urothelial carcinoma) and are choosing to have your bladder surgically removed (radical cystectomy) - You are willing to participate in phone follow-up at 30 and 90 days after surgery **You may NOT be eligible if...** - Your bladder removal surgery is for a non-cancer reason (such as chronic pain or fistula) - Your cancer originated in another organ (such as the rectum or uterus) - You have very advanced local disease requiring removal of multiple pelvic organs - You have heart, kidney, or liver disease that makes IV fluid therapy unsafe - You are unwilling or unable to participate in follow-up calls Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERIntravenous fluids

At home, the patient receives a 1L bolus of either lactated ringers or normal saline three times a week for four weeks with the patient's home nurse.

OTHERERAS

Patients assigned to not receive home IVF will receive everything in the investigator's current ERAS protocol except the home intravenous fluid program. Patients without preexisting vascular access will not receive a midline catheter post-operatively, however the participant will still receive home care for skilled nursing who will provide wound care, ostomy teaching, and education about perioperative fluid management.